MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES CA/USA CAMINO CATHETER, UNKNOWN; N/A

Catalog Number XXX-CATHETER

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2015

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device involved in the reported incident is expected to be returned for evaluation.An investigation has been initiated based upon the reported information.

Event Description

This is the second of two reports.This is in regards to the second catheter.Poor connection to the camino monitor was reported.Additional information was requested and on 16oct2015, the following was provided by the customer: a (b)(6) year old male patient had injuries: motorcycle versus semi- scattered subarachnoid hemorrhage (sah), shearing.When trying to zero the catheter to atmosphere while the bolt was out of the patient's head, the camino read "no catheter connection".The catheter was changed out.The physician was able to zero the catheter.The bolt was inserted into the patient.The intracranial pressure (icp) read 30's.It was unknown if the dura mater was opened per instructions for use (ifu) prior to bolt/catheter insertion.The catheter was pulled back slightly after insertion.The catheter was dressed with 2 tegaderms and the cable was secured with the clip.One hour later, the bolt was reading -39.Three other camino monitors were used and it all read -39.The physician returned 3 hours later, switched the zeroing cables (black box connection) with no improvement.The physician then re-threaded a bolt from the operating room (or) stock and the icp had a nice waveform and read 10.There was no patient injury.There was a delay in intracranial pressure (icp) readings.There was no patient consequences as a result of the delay.Request for additional clarification was sent to the customer (verification of how many catheters were used on the patient).

Manufacturer Narrative

Integra has completed their internal investigation on 2/10/2016.The customer did not return the catheter for investigation.(b)(4).Based on the information and description of the incident received from the complainant does not allow for confirmation nor denial of reasonably foreseeable misuse of the catheter.Additionally, because the product was not returned for evaluation, no root cause could be established for the failure mode described in the customer complaint.

• Brand Name: CAMINO CATHETER, UNKNOWN
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5213710
• MDR Text Key: 30867884
• Report Number: 2023988-2015-00044
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K102875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR